SciPro · 1 day ago
Senior Director Pharmacovigilance & Safety Operations
San Diego, CA
Full-time
Onsite
Director/Executive
$280K/yr - $300K/yr
12+ years expSciPro Global is partnered with a company working across various therapeutic areas seeking to hire a Senior Director Drug Safety Operations. This role is responsible for overseeing adverse event case management, safety database operations, vendor oversight, and ensuring regulatory compliance.
EmploymentOutsourcingRecruitingStaffing Agency
Hiring Manager
Hannah Wyllie, M.S.Ed.
Responsibilities
Oversee end-to-end SAE, SUSAR, and ICSR management, ensuring timely and compliant reporting to global health authorities
Ensure compliance with all domestic and international pharmacovigilance regulations across development programs
Manage and oversee safety vendors and CROs, including case processing, database management, reconciliation activities, TMF filing, and contractual deliverables
Lead the setup of safety operations for new studies, including Safety Management Plans, Safety Monitoring Plans, and system configurations
Maintain and oversee safety databases (e.g., ARGUS), including UAT, upgrades, disaster recovery, and business continuity testing
Support preparation, submission, and review of aggregate safety reports (DSURs, IND Annual Reports, PSUR/PBRER, PADERs)
Develop, maintain, and oversee PV agreements (PVAs/SDEAs) and ensure partner compliance
Perform secondary quality review of safety cases and support ongoing quality and inspection-readiness activities
Collaborate cross-functionally with Clinical Operations, Regulatory Affairs, Quality, and external partners to support safety oversight
Support signal detection activities, safety trend analysis, and risk management planning
Contribute to safety content for clinical trial protocols, investigator brochures, informed consent forms, CRFs, and clinical study reports
Support DSMB and DSC meetings through safety data preparation and analysis
Author, review, and maintain SOPs, work instructions, and safety process documentation
Provide leadership, mentorship, and operational support to Drug Safety Operations team members
Qualification
Required
12–15 years of experience in Drug Safety / Pharmacovigilance Operations
Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field
Extensive hands-on experience with safety case management and processing
Strong working knowledge of safety databases (ARGUS, ArisG, or similar)
Experience with MedDRA and WHO Drug coding
Proven experience preparing and reviewing aggregate safety reports for investigational and/or marketed products
Solid understanding of ICH E2B and global PV regulations
Demonstrated leadership, organizational, and multi-tasking capabilities
Experience leading and managing a team
Benefits
20% Bonus
Stock
Company
SciPro
SciPro is a staffing agency specializing in the life sciences field and offers regulatory affairs, biometrics, and clinical operations jobs.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase